Pessary for pelvic organ prolapse

ABSTRACT

A collapsible pessary is provided, and can have a stem and at least one rotating petal member that can rotate between a collapsed state with a smaller diameter and a deployed state with a larger diameter. The collapsible pessary can have a plunger within the stem, and pushing the plunger upwards can cause the plunger to push upwards on a portion of the petal member, thereby causing the petal member to rotate into a deployed position. The pessary can be in a collapsed state wherein its overall diameter is at a minimum, or a deployed state, wherein its overall diameter is at a maximum.

RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application Ser.No. 62/563,443, entitled PESSARY FOR PELVIC ORGAN PROLAPSE, filed Sep.26, 2017, the teachings of which are incorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to pessaries for use in treating pelvic organprolapse, and more specifically, to removable pessaries

BACKGROUND OF THE INVENTION

About 50 percent of women over the age of 50 suffer from some degree ofpelvic organ prolapse (“POP”). The female pelvic organs include thebladder, uterus, vaginal canal and rectum. A prolapse is a medicalcondition in which at least one organ of the body has slipped forward ordownward. Pelvic organ prolapse can result from weakening of the pelvicfloor muscles and loss of integrity of the pelvic floor connectivetissue of which allows for abnormal uterine or vaginal descent. Incertain cases, the uterus can descend through the opening to the vaginalcanal. Contributory factors for POP can include hard labors with longepisodes of pushing, large babies, smoking, obesity, connective tissuedisorders, upper respiratory disorders and repetitive strain injuries.The severity of POP can range from minor and asymptomatic to more severedegrees requiring medical intervention. In the latter case, women canchoose to undergo reconstructive surgery using a surgically implantedmesh or a native tissue repair to resuspend the fallen structures.Alternatively, women can manage non-surgically with a pessary.

FIG. 1 of the prior art presents a case of POP in which certain of thepelvic organs have descended from a female pelvic region 100. The femalepelvic region 100 is shown in a side view such that the front side 102is oriented to the left and the rear side 104 is to the right. Thepelvic region 100 is supported by a skeletal frame 106. A plurality ofprolapsed organs 108 have descended from the pelvic region below thepelvic floor axis 109 that corresponds to a plane running from front torear along the bottom of the pelvic region. Ordinarily, the pelvicorgans are disposed above axis 109. The prolapsed organs 108 that havedescended below axis 109 to include a bladder 110, a uterus 112 and thevaginal canal 114. In the case of the vaginal canal 114, this organ hasbecome inverted, such that the interior lining is now an exteriorsurface, to the great discomfort of the person for whom it is anordinary recessed organ. A rectum 116 remains situated above axis 109,but it is contemplated that eventually, it can descend through axis 109to join the other prolapsed organs 108.

A pessary is a device that can be inserted into the vaginal canal tosupport the descending organs. Pessaries can be recommended for womenwho do not wish to undergo surgery, for pregnant women, or for womenwith other serious health issues which makes surgery too risky.Pessaries are primarily made of medical grade silicone, with somecontaining internal plastic support structures for added rigidity. Infunction, the pessary resides in the vaginal canal and provides verticalsupport for the uterus, as well as lateral support for the bladderand/or rectum, if also prolapsed.

FIG. 2 of the prior art shows a pessary 200 inserted into the vaginalcanal 114 to support the prolapsed organs 108 of FIG. 1. The pessary 200can be placed in the vaginal canal 114 just above axis 109 and can stayin place due to residual tone of the pelvic floor muscle group 202 andat least one of a suction, a friction force and/or larger size (so as tocause the vaginal wall to indent around the perimeter of the pessary200). When in position, the pessary supports the organs above it andprevents them from impinging upon or passing through the vaginal canal.However, pessaries can cause erosion of the vaginal lining (epithelium)if they are inappropriately sized or left in situ for prolonged periods.To fit a pessary, a healthcare practitioner (for example, a physician, aphysician's assistant, a nurse or midwife) assesses the size of thevaginal canal, introitus (opening) 204 and depth. The pessary can belubricated, inserted and positioned behind the pubic symphysis 206 (abony structure in the skeletal frame 106). Pessaries in the prior arttend to be rigid and difficult to remove and re-insert by the useralone. Many women return to the practitioner every three to six monthsto have their pessary removed, cleaned and replaced. Some women are ableto remove and clean their pessaries themselves. The recommendations forself-cleaning have not been standardized, but for example, currentCanadian practice advises any woman who is able to remove her ownpessary to remove, wash and replace it once per week. Pessaries can becumbersome and uncomfortable to insert and remove. The average pessaryuser is a postmenopausal woman and these women often experience vaginalatrophy and dryness as well as narrowing of the vaginal canal introitus,creating the potential for further difficulty and discomfort ofinsertion and removal. Currently available pessaries are manually foldedor compressed to some degree before insertion. Although this can behelpful with enhancing the ease and comfort of the insertion, currentlyavailable pessaries are not able to significantly decrease incross-sectional area. During removal it can be difficult to fold thepessary, often resulting in the pessary being removed in its full orclose to full size and shape. These attributes make self-maintenance ofthe pessary very painful, if not impossible, and consequently, onlyapproximately 5% of women with a pessary are able to remove, clean, andinsert their own pessaries. Furthermore, some pessaries are notremovable by the patient at all.

The relative rigidity of pessaries and the difficulties in removal canresult in a reliance on a healthcare practitioner for regular cleaning,an inability to experience vaginal intercourse and the pessary remaininginserted even when not necessary. It would be desirable for a pessary tobe readily inserted and removed by the user, thereby improving thequality of life for that user.

SUMMARY OF THE INVENTION

A pessary overcomes the disadvantages of the prior art by providing acollapsible pessary that can be readily inserted, removed and cleanedwithout the assistance of a health practitioner. In an embodiment, apessary can consist of a stem and at least one petal member hingedlyattached to an insertion end of the stem. The at least one petal membercan rotate between a collapsed state and a deployed state. In thedeployed state, the at least one petal member can extend outward fromthe stem, and in the collapsed state, the at least one petal member canbe rotated upwards so that the diameter of the pessary is smaller in thecollapsed state than in the deployed state. The pessary can have aplunger that can move within the stem along a vertical axis of the stem,wherein the plunger can slide away from the insertion end of the stem toallow the at least one petal member to rotate upwards into the collapsedstate, and the plunger can slide towards the insertion end of the stemto push the at least one petal member into the deployed state. When theplunger is pushed towards the insertion end of the stem, a top of theplunger pushes upwards on the short segment causing the at least onepetal member to rotate into the deployed state with the elongatedsegment extending outwards from the stem. The pessary can include aconnection between the top of the plunger and the short segment of theat least one petal member, and when the plunger is pulled away from theinsertion end of the stem, the top of the plunger can pull the shortsegment inwards and downwards, thereby rotating the elongated segmentupwards into the collapsed state. The pessary can include a shelf at theinsertion end of the stem, so that when the pessary is in a deployedstate, the at least one petal member can be supported by the shelf. Thepessary can include at least one sliding hinge between the stem and theat least one petal member. The sliding hinge can be hingedly attached tothe at least one petal member, and the sliding hinge can be slidablyattached within the interior of the stem. The sliding hinge can slidealong the interior of the stem in a direction parallel to the verticalaxis. The pessary can include a deformable membrane that can beconnected to and located between a plurality of short segments. Thedeformable membrane can be connected to the top of the plunger. The atleast one short segment can be connected to the top of the plunger. Theat least one petal member can include a tab at the bend, and the plungercap can have at least one groove, so that when the pessary is in adeployed state, the tab can be engaged with the groove. The at least onepetal member can include at least two petal members, and the pessary caninclude an outer rim, so that the outer rim connects the at least threepetal members thereby forming a unitary petal member. The at least onepetal member can include at least two petal members, and the pessary caninclude a petal webbing between the petal members, the petal members andthe petal webbing forming a unitary petal member. The pessary caninclude a stem cap, and in a deployed position, the short segment can beheld between the plunger and the stem cap, thereby preventing the petalmember from rotating out of the deployed position. The petal members caninclude an intermediate segment, and in a deployed state, the plungercan prevent the short segment from rotating upwards, thereby preventingthe petal member from over-rotating out of the deployed position, andthe plunger can prevent the intermediate segment from rotating inwards,thereby preventing the petal member from rotating back to the collapsedstate. In the collapsed state, the at least one petal member can besubstantially parallel to a vertical axis of the stem.

In an embodiment, a method of inserting a pessary can include collapsingthe pessary into a collapsed state by rotating an elongated member of atleast one petal member upwards to decrease the diameter of the pessary;inserting the pessary into the vaginal canal; and pushing a plungerupwards into a stem of the pessary, so that a top of the plunger pushesagainst the petal members, thereby extending the petal members outwardsinto a deployed state.

In an embodiment, a method of removing a pessary can include pulling aplunger downwards from the stem of a pessary, thereby allowing petalmembers to rotate out of a deployed state; and pulling the pessarydownwards, thereby allowing the petal members to rotate into a collapsedstate, decreasing the diameter of the pessary; and removing the pessaryfrom the vaginal canal.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention description below refers to the accompanying drawings, ofwhich:

FIG. 1 is a cross sectional view of the pelvic organs in a prolapsedstate, according to the prior art;

FIG. 2 is a view of an inserted pessary, according to the prior art;

FIG. 3 is a perspective view of a pessary for pelvic organ prolapse in acollapsed state, according to an embodiment;

FIG. 4 is a view of the pessary in a deployed state, according to anembodiment;

FIG. 5 is a view of the pessary in a deployed state, according to anembodiment;

FIG. 6 is a cross-sectional view of the pessary along cross section line6-6 of FIG. 3, according to an embodiment;

FIG. 7 is a cross-sectional view of the pessary along cross section line7-7 of FIG. 4, according to an embodiment;

FIG. 8 is a view of a pessary with a connection between the plunger capand the petal members shown in a collapsed state, according to anembodiment;

FIG. 9 is a view of the pessary of FIG. 8 with a connection between theplunger cap and the petal members and shown in a deployed state,according to an embodiment;

FIG. 10 is a view of a pessary with a sliding joint interface in a firstcollapsed state for insertion, according to an embodiment;

FIG. 11 is a view of the pessary of FIG. 10 with a sliding jointinterface in an intermediary state, according to an embodiment;

FIG. 12 is a view of the pessary of FIG. 10 with a sliding jointinterface in a deployed state, according to an embodiment;

FIG. 13 is a view of the pessary of FIG. 10 with a sliding jointinterface in a second collapsed state for removal, according to anembodiment;

FIG. 14 is a view of a pessary with a connecting deformable membrane ina collapsed state, according to an embodiment;

FIG. 15 is a view of the pessary of FIG. 14 with a connecting deformablemembrane in a deployed state, according to an embodiment;

FIG. 16 is a view of a pessary with notches in the plunger cap and shownin a collapsed state, according to an embodiment;

FIG. 17 is a view of the pessary of FIG. 16 with notches in the plungercap and shown in a deployed state, according to an embodiment;

FIG. 18 is a view of a pessary that can be operated without a plunger,shown in a collapsed state according to an embodiment;

FIG. 19 is a view of the pessary of FIG. 18 that can be operated withouta plunger, shown in a deployed state according to an embodiment;

FIG. 20 is a perspective view of a unitary petal member for a pessary,according to an embodiment;

FIG. 21 is a top view of a unitary petal member for a pessary, accordingto an embodiment;

FIG. 22 is a top view of a unitary petal member for a pessary with threesupport members, according to an embodiment;

FIG. 23 is a view of a unitary petal member for a pessary with closelyarranged cutout grooves, according to an embodiment;

FIG. 24 is a view of a unitary petal member for a pessary with petallobes, according to an embodiment;

FIG. 25 is a view of a unitary petal member for a pessary with acircular profile, according to an embodiment;

FIG. 26 is a view of a unitary petal member for a pessary with a lobedouter rim, according to an embodiment;

FIG. 27 is a view of a stem with rectangular cavities for petal members,according to an embodiment;

FIG. 28 is a view of a stem with trapezoidal cavities for petal members,according to an embodiment;

FIG. 29 is a view of a stem with an alternate cavity shape, according toa an embodiment;

FIG. 30 is a view of a stem with a cavities having no ceiling, accordingto an embodiment;

FIG. 31 is a partial view of a pessary with a rigid stem cap in acollapsed state, according to an embodiment;

FIG. 32 is a partial view of the pessary with a rigid stem cap of FIG.31, shown in a deployed state, according to an embodiment;

FIG. 33 is a partial view of a pessary with petals that can be held inplace by a plunger, shown in a collapsed state, according to anembodiment;

FIG. 34 is a partial view of the pessary of FIG. 33 with the petals in adeployed state, according to an embodiment;

FIG. 35 is a perspective view of a pessary with webbing between petals,according to an embodiment;

FIG. 36 is a perspective view of a domed pessary with resilientdeformable petals, according to an illustrative embodiment;

FIG. 37 is a perspective view of a pessary with resilient deformablemembers connected to a base ring, according to an embodiment;

FIG. 38A is a side view of the domed pessary of FIG. 37 shown in acollapsed conformation, according to an illustrative embodiment;

FIG. 38B is a bottom view of the domed pessary of FIG. 37 shown in acollapsed conformation, according to an illustrative embodiment;

FIG. 38C is a top view of the domed pessary of FIG. 37 shown in adeployed conformation;

FIG. 39A is a diagram of a figure-eight pessary in a deployedconformation, according to an illustrative embodiment;

FIG. 39B is a detailed view of the apex region A from FIG. 39A,according to an illustrative embodiment;

FIG. 39C is a detailed view of the hinge region B from FIG. 39A,according to an illustrative embodiment;

FIG. 39D is a detailed view of the hinge region B from FIG. 39A,according to another illustrative embodiment;

FIG. 39E is a detailed view of the central union region C from FIG. 39A,according to an illustrative embodiment;

FIG. 40A is a diagram of a figure-eight pessary in a collapsedconformation, according to an illustrative embodiment;

FIG. 40B is a detailed view of the central union region A from FIG. 40A,according to an illustrative embodiment;

FIG. 41 is a diagram of a pessary with petals that rotate about acentral axis, according to an illustrative embodiment;

FIG. 42A is a partially cutaway diagram of the pessary of FIG. 41showing inner workings of the pivoting hinge and shown in a collapsedstate, according to an illustrative embodiment;

FIG. 42B is a cutaway view of a central pivoting hinge for the pessaryof FIG. 41 showing inner workings and shown in a deployed state,according to an illustrative embodiment;

FIG. 43 is a cutaway view of a central pivoting hinge for the pessary ofFIG. 41 showing inner workings and in a deployed state, according toanother illustrative embodiment;

FIG. 44 is a perspective view of a pessary with enclosed rotatingpetals, according to an illustrative embodiment;

FIG. 45 is a perspective view of the pessary of FIG. 44, shown in thecollapsed state;

FIG. 46 is a cross section of the pessary of FIG. 44 in the deployedstate, taken along line 46-46 of FIG. 44, according to an illustrativeembodiment;

FIG. 47 is a partially cutaway view of a rotating pessary that can bedisassembled for cleaning, according to an illustrative embodiment;

FIG. 48 is a perspective view of a pessary with a sliding ring lock,according to an illustrative embodiment;

FIG. 49 is a perspective view of the pessary of FIG. 48 in a collapsedstate, according to an illustrative embodiment;

FIG. 50 is a perspective view of the pessary of FIG. 48 in a deployedstate, according to an illustrative embodiment;

FIG. 51A is a perspective view of a locking mechanism for the pessary ofFIG. 48, according to an illustrative embodiment;

FIG. 51B is a partially cut away perspective view of a locking mechanismfor the pessary of FIG. 48 and shown in a deployed state, according toanother illustrative embodiment;

51C is a partially cut away perspective view of a locking mechanismpessary of FIG. 51B and shown in a collapsed state, according to theillustrative embodiment;

FIG. 51D is a partial perspective view of an upper portion of a pessarywith a sliding ring, according to another embodiment;

FIG. 51E is a partial perspective view of the upper portion of thepessary of FIG. 51B shown in a collapsed state, according to theembodiment;

FIG. 52 is a top view of a pessary with a rotating ring lock, accordingto an illustrative embodiment;

FIG. 53 is a cross sectional view of the pessary with a rotating ringlock taken along cross section line 53-53 of FIG. 52, according to anillustrative embodiment;

FIG. 54 is a top view of a pessary with a rotating ring lock in acollapsed state, according to an illustrative embodiment;

FIG. 55 is a cross sectional view of the pessary of with a rotating ringlock in a collapsed state, taken along cross section line 55-55 of FIG.54, according to an illustrative embodiment;

FIG. 56 is a perspective view of a pessary with a twisting deploymentshown in a deployed state, according to an illustrative embodiment;

FIG. 57 is a perspective view of the pessary with a twisting deploymentshown in a collapsed state, according to an illustrative embodiment;

FIG. 58 is a perspective view of the pessary with a twisting deploymentof FIG. 56 showing a locking mechanism, according to an illustrativeembodiment;

FIG. 59 is a partially cut away perspective view of the pessary with atwisting deployment of FIG. 56 showing the interior of the petals,according to an illustrative embodiment; and

FIG. 60 is a perspective view of the pessary with a twisting deploymentof FIG. 56 showing living hinges, according to an illustrativeembodiment.

DETAILED DESCRIPTION

FIG. 3 is a perspective view of a pessary for pelvic organ prolapse in acollapsed state, according to a first embodiment. A vaginal pessary 300can be used for treatment of pelvic organ prolapse, and can beretractable and/or collapsible. The pessary 300 can be easily insertableand removable when in a collapsed state. The pessary 300 can include aplurality of L-shaped petal members 310, a hollow stem 320 that caninclude a shelf 318 at or near the top of the hollow stem 320, a plunger330 that can include a plunger cap 380 and can reside within the hollowstem 320, and at least one connection to join the petal member 310 tothe top of the stem 320. In an embodiment, a pessary can be providedwith four rigid or semi-rigid L-shaped petal members 310 with roundededges 311. In various embodiments, a pessary can have more than or fewerthan four petal members. The L-shaped petal members 310 can have alonger segment 314 that is the upper portion of the “L” shape, and ashorter segment 316 that is the lower portion of the “L” shape, so thatthe elongated segment 314 and the shorter segment 316 can have an anglebetween them. Each of the petal members 310 can be constructed with arotation point 317 that can define a bend, or a point of transition,between the elongated segment 314 and the short segment 316. The petalmembers 310 can be attached to the stem 320 at a hinge. The long segment314 can rotate from the approximately vertical orientation as shown inFIG. 3, to a position that can be approximately perpendicular to avertical axis VA that describes a central line extending through andfrom the top end 350 through the bottom end 360. The material of thepessary can be a biocompatible FDA (U.S. Food and Drug Administration)approved silicone or plastic material. The exterior edges of the petalmembers can be rounded off, to avoid any sharp edges that might causeinjury, infection or irritation to the user.

In the collapsed state shown in FIG. 3, the plunger 330 and plunger cap380 can be in a lowered position with respect to the stem 320, and canbe out of contact with the short segment 316. The short segment 316 canbe oriented inwards towards the vertical axis VA, and the elongatedsegment 314 can be oriented upwards so as to be substantially alignedwith the vertical axis VA. In the collapsed state the overall diameterof the pessary is at a minimum. Although the elongated segments 314 arereferred to herein as being vertical, or parallel with the vertical axisVA, when they are in the collapsed state, it should be clear that theelongated segments 314 can hinge inward to a position beyond vertical,so that the elongated segments 314 are leaning inward towards thevertical axis, however, for the sake of clarity and readability, thecollapsed state will be referred to herein as being vertical or parallelto the vertical axis.

The elongated segment 314 can have a length PL that can vary dependingon the overall width of the pessary, which can be dependent upon thesize of the vaginal canal introitus. In various embodiments, the lengthPL of a petal member can be in a range from approximately 0.75 toapproximately 2.5 inches (±0.25 inches). The stem 320 can be a hollowcylinder with a shelf 318 at its uppermost end. Shelf 318 can beco-formed with the stem 320. The shelf 318 can provide a resting placefor the petal members when deployed, as well as a stopping point for therotation of the petal members. The stem can include indented grippingsurfaces 322 that can improve gripping during insertion and removal. Aplunger 330 can be provided at the bottom end 360. When pushed upwards,the plunger can cause deployment of the petal members 310. As usedherein, the directional terms, such as, but not limited to, “up” and“down”, “upward” and “downward”, “rear”, “rearward” and “forward”,“top”, “topmost” and “bottom”, “inside” and “outer”, “front” and “back”,“inner” and “outer”, “interior” and “exterior”, “downward” and “upward”,“horizontal” and “vertical” should be taken as relative conventionsonly, rather than absolute indications of orientation or direction withrespect to an acting direction of the force of gravity.

FIG. 4 is a view of a pessary in a deployed state, according to anembodiment. Turning to FIGS. 3 and 4, a pessary 300 can be arranged ineither a collapsed state or a deployed state. The collapsed state issuitable for the insertion and removal of the pessary, and can bedefined as the configuration in which the plunger 330 is at its lowestposition and the elongated segment of each of the L-shaped petal memberscan be parallel with the vertical axis VA and the shorter segment ofeach petal member can be oriented inwards. In the collapsed state, theshorter segments 316 can protrude into the center of the stem. When thepessary is in its collapsed state, the diameter of the pessary is at aminimum. When the pessary is in a deployed state, the plunger 330 can beat an uppermost position, the plunger cap 380 can be protruding from thestem, and the elongated segments 314 of each of the petal members 310can be resting upon and supported by the shelf 318 such that each of theelongated segments 314 can be extended outwards from the vertical axisVA. The pessary 300 can be deployed to the deployed state afterinsertion into the vaginal canal. In the deployed state, the pessary canhave a maximum deployed diameter DD at the widest location. The deployeddiameter DD of the pessary in the deployed state can vary based upon thesize of the vaginal canal introitus. In an embodiment, the diameter DDof a deployed pessary can be in a range from approximately 1.75 toapproximately 5 inches (±0.25 inches). The overall diameter of thepessary in a deployed state is greater than the overall diameter of thepessary in a collapsed state.

A pessary can be inserted by introducing the top end 350 of the pessary300 into the opening of the vaginal canal and pushing upwards along thevaginal canal (and inwards with respect to the vaginal canal) until thepessary is in a desired position. Once the pessary 300 is inserted intothe vaginal canal to the desired position, the plunger 330 can be pushedupwards within the hollow stem 320 to its highest position. As theplunger 330 moves upwards, the plunger cap 380 can engage with and pushupwards on the short segment 316 of each petal member 310, therebycausing a rotational motion of the petal members. As the petal members310 rotate, the elongated segments 314 can move downwards and outwards.The members can rotate approximately 90 degrees or more such that theshort segments are approximately vertical (aligned so as to be parallelto the vertical axis VA) and the elongated segments 314 can beapproximately perpendicular to the vertical axis VA. In this state, theelongated segments 314 can make contact with and can be supported by theshelf 318. The plunger 330 can remain at its highest position in thestem when the pessary is in its deployed state, and can constrain theL-shaped petal members 310 from rotating and returning to the collapsedstate. When the plunger 330 is pulled downwards, the petal members 310are no longer restrained and are thus free to rotate to the collapsedstate with the elongated segments 314 in the vertical position. Thepessary can have the smallest diameter in the collapsed state.

FIG. 5 is a view of a pessary in a deployed state, according to anembodiment. The pessary 300 is shown in a deployed state within avaginal canal 114 for support of a uterus 116 as a therapy for pelvicorgan prolapse. Pessary 300A shows the pessary in a collapsed stateprior to insertion and deployment. In its collapsed state, a pessary canhave a collapsed diameter CD of approximately 1 inch (±0.5 inches). Asoft silicone overmolding can provide for greater comfort duringinsertion, removal and deployment of the pessary.

FIG. 6 is a cross-sectional view of the pessary along cross section line6-6 of FIG. 3, according to an embodiment. FIG. 6 shows the petalmembers 310 in a collapsed state. A plurality of joints 390 can besituated along the top end of the stem 320 and can connect the stem 320with the petal members 310. Each petal member 310 can be connected tothe stem 320 by at least one joint 390. The joint 390 can be aninterface between the stem and each of the petal members and can retainthe petal members in connection with the stem during rotation and thestates of collapsed and deployed. The joint 390 can be a hingestructure. It is contemplated that in other embodiments, the joint 390can be a ring-like circumferential feature. In the collapsed state, theplunger cap 380 can be situated within the stem 320, below the shortsegments 316 of each of the petal members 310.

FIG. 7 is a cross-sectional view of the pessary along cross section line7-7 of FIG. 4, according to an embodiment. FIG. 7 shows the petalmembers in the deployed state. In the deployed state, the plunger cap380 can be situated at the top end of the stem 320, engaging the shortsegments 316 of each of the petal members 310. During movement from thecollapsed state to the deployed state, the motion of the petal memberscan be initiated when the plunger cap 380 is pushed upwards, coming intocontact with the short segments 316 and urging them to rotate outwardsas the plunger cap rises in the stem. When a removal of the pessary isdesired, the plunger is moved to its downward position in the stem,drawing the plunger cap 380 downwards and out of contact with the petalmembers 310, allowing the elongated segments to return to the verticalorientation as the stem is pulled downwards.

FIG. 8 is a view of a pessary in a collapsed state and with a connectionbetween the plunger cap and the petal members, according to anembodiment. In an embodiment, a pessary 800 can have a connection 802that can be connected at one end to the top surface of the plunger cap380, and can be connected at the other end to each of the short segments316 of the petal members 310. The pessary 800 is depicted in a collapsedstate in FIG. 8. Connection 802 can be fixed at its ends so that it canserve as a hinge during the movements (upwards and downwards) of theplunger cap 380. When the pessary 800 is converted from a deployed stateto a collapsed state by pulling down on the plunger, the connections 802can pull the short segments 316 inward and downward, thereby rotatingthe elongated segments 314 upward and inward into the collapsed state.

FIG. 9 is a view of the pessary in a deployed state and with aconnection between the plunger cap and the petal members, according toan embodiment. When the pessary 800 is converted from a collapsed stateto a deployed state by pushing the plunger up into the stem 320, theconnections 802 can urge the short segments 316 upwards and outwards,thereby rotating the elongated segments outward and downward into thedeployed state.

FIGS. 10-13 show a pessary with a sliding joint interface, according toan embodiment. A pessary 1000 can have a connection 1002 that can be asliding joint interface between the petal members 310 and the stem 320.The connection 1002 can slide up and down within the stem 320, and canpermit the petal members 310 to rotate at the connection 1002. FIG. 10is a view of a pessary with a sliding joint interface in a firstcollapsed state, according to an embodiment. In the first collapsedstate shown in FIG. 10 the pessary 1000 is in a pre-insertion state andis ready for insertion. The plunger cap 380 can be below the shortsegments 316 of the petal members 310. The plunger cap 380 can be out ofcontact with the petal members 310 in the first collapsed state. Thesliding connections 1002 are in their lowest position in the stem. Thesliding connections 1002 can reside in part in grooves (not shown) onthe interior surface of the stem 320, and the sliding connections 1002can move upwards and downwards within the grooves. In the pre-insertionstate, the petal members can be at least partially contained within thestem 320. In this pre-insertion state, the stem 320 can retain theelongated members 314 in a collapsed state, so that they cannot rotateinto a deployed state during the insertion process.

FIG. 11 is a view of the pessary of FIG. 10 with a sliding jointinterface in an intermediary state, according to an embodiment. In FIG.11, the plunger 330 is shown in an intermediate state, and movingupwards into a deployed position. The plunger cap 380 can be in contactwith the short segments 316 of the petal members 310. In theintermediate state, the plunger cap 380 can begin urging the petalmembers 310 upwards until they emerge above the shaft 320. As the petalmembers move upwards, the sliding connections 1002 also move upwards tothe top of the shaft. When the sliding connections 1002 and the petalmembers 310 reach the end of their travel at the top of the shaft, theplunger cap 380 can push the short segments 316 upwards and outwards, sothat the petal members 310 can begin to rotate at the slidingconnections 1002. As the petal members 310 rotate, the elongatedsegments 314 can swing outwards and downwards towards the deployedposition.

FIG. 12 is a view of the pessary of FIG. 10 with a sliding jointinterface in a deployed state, according to an embodiment. The plungercap 380 and the sliding connections 1002 are at their highest positionin the stem. The elongated segments 314 are in the deployed position andare resting on and supported by the shelf 316.

FIG. 13 is a view of the pessary of FIG. 10 with a sliding jointinterface in a second collapsed state for removal, according to anembodiment. The plunger cap 380 can be below the short segments 316 inthe stem 320 and can be out of contact with the petal members 310. Theplunger cap 380 can be at its lowest position in the stem 320. Thesliding connections 1002 can remain in their highest position in thestem. As the pessary is removed in a downward movement through thevaginal canal, the walls of the vaginal canal can urge the petal members310 to move upwards into the vertical orientation.

FIG. 14 is a view of a pessary with a connecting deformable membrane ina collapsed state, according to an embodiment. A pessary 1400 can have aconnecting deformable membrane 1412 that connects petal members 1410.The pessary 1400 can have connections 1420 that can connect the petalmembers 1410 to the shaft 320. The pessary 1400 can have a connection1422 that connects the membrane 1412 to the plunger cap 380. The petalmembers 1410 can have an obtuse angle between the elongated segment 1414and the short segment 1416. The short segments 1416 can be at leastpartially embedded within the deformable membrane 1412. In the collapsedstate shown in FIG. 14, the deformable membrane can bulge inwards anddownwards towards the interior of the shaft 320. In the collapsed state,the elongated segments 1414 can be in an approximately verticalorientation and can be aligned parallel to vertical axis VA. Connections1420 join the petal members 1410 to the stem 320 and can function as ahinging joint. Connection 1422 joins the plunger cap 380 to thedeformable membrane 1412.

FIG. 15 is a view of the pessary of FIG. 14 with a connecting deformablemembrane in a deployed state, according to an embodiment. In thedeployed state, the plunger cap 380 can be at its highest position inthe stem 320, pushing up on the deformable membrane 1412 and causing itto bulge upwards. When the deformable membrane 1412 and short segments1416 are pushed upwards by the plunger cap 380, the elongated segments1414 rotate outwards and downwards around connections 1420 until theyare in the deployed position, which can be perpendicular to the verticalaxis VA. As the plunger is pushed upwards, the plunger cap 380 can pushupwards on the deformable membrane 1412 through connection 1422, causingthe petal members 1410 to rotate into the deployed position shown inFIG. 15. When the plunger is pulled downwards, the deformable membrane1412 can be pulled downwards by connection 1422, causing the petalmembers to rotate back into the collapsed position shown in FIG. 14.

FIG. 16 is a view of a pessary with notches in the plunger cap and shownin a collapsed state, according to an embodiment. A pessary 1600 canhave silicone overmoldings 1602, a stem cap 1604, and a plunger cap 1610that can include notches 1612. Stem cap 1604 can be a deformablemembrane, or stem cap 1604 can be a rigid or semi-rigid cap. The pessary1600 can have petal members 1620 with tabs 1622 near the hinge. Notches1612 can engage the petal members 1620 at tabs 1622 to lock the petalmembers in a deployed state. Silicone overmoldings 1602 can cover theelongated segments of the petal members 1620, and can provide the petalmembers 1620 with a covering that can increase comfort for the user. Inthe collapsed state shown in FIG. 16, the plunger cap 1610 can be in aresting position that can be out of contact with the petal members 1620.The stem 1630 can include a shelf 1632 to support the petal members 1620in the deployed state. In the collapsed state, the petal members 1620can be in an approximately vertical orientation and aligned with thevertical axis VA.

When the pessary 1600 is manufactured, a hollow plunger 1640 can beinserted into the stem 1630. The plunger cap 1610 can have a plug 1642within the bottom of the plunger cap 1610, and the plunger cap 1610 canbe seated on the hollow plunger 1640 by insertion of the plug 1642 intothe hollow plunger 1640. Petal members 1620 can then be added to the topof the stem 1630.

FIG. 17 is a view of the pessary of FIG. 16 with notches in the plungercap and shown in a deployed state, according to an embodiment. Plungercap 1610 can be pushed upwards in the stem, and the plunger cap 1610 canpush upwards on the stem cap 1604 and/or petal members 1620, therebyrotating the petal members 1620 into a deployed position. In thedeployed position, the petal members 1620 can be supported on the shelf1632. In the deployed position, tabs 1622 can engage with grooves 1612,thereby locking the pessary 1600 in a deployed state. The tabs 1622engaged in the grooves 1612 can hold the plunger cap 1610 in the upwardposition, thereby locking the petal members 1620 in the outstretchedposition.

FIG. 18 is a view of a pessary that can be operated without a plunger,shown in a collapsed state according to an embodiment. Pessary 1800 canbe free of a plunger. This plungerless pessary 1800 can be inserted,deployed and removed with the assistance of an applicator. FIG. 18 showspessary 1800 in a collapsed state. The pessary 1800 can include a hollowstem 1810 and a plurality of petal members 1820. An applicator can holdthe petal members in the collapsed state during the insertion process,and then the applicator can be removed after insertion, so that thepetal members can rotate into the deployed state. The stem 1810 can beprovided with a shelf 1811 at one end for supporting the petal members1820. The stem 1810 can have cavities 1812 at or near the top edge ofthe stem. Cavities 1812 can allow petal members 1820 to rotate withinthe cavities 1812. The number of cavities 1812 can be the same as thenumber of petal members 1820. The petal members 1820 can have an outerlayer of silicone overmolding 1822 over a rigid interior layer 1824. Ahinged lower edge 1826 can be connected to the stem 1820 by a snapfitted nub in a socket.

FIG. 19A is a view of the pessary of FIG. 18 in a collapsed state withan applicator. The applicator 1900 can constrain the pessary 1800 in thecollapsed state for insertion. In various embodiments, a pessary 1800can have resilient hinge members 1902 that can be a silicone or otherstretchable material. When the pessary 1800 is in the collapsed statewithin the applicator housing 1904, the petals 1820 have been rotatedupwards and the silicone hinge 1902 can be stretched. After the pessary1800 and applicator 1900 have been inserted into the vaginal canal, auser can push up on the plunger 1906 to eject the pessary 1800 out ofthe applicator housing 1904.

FIG. 19B is a view of the pessary 1800 that has been ejected from theapplicator 1900. When the pessary 1800 is ejected out of the applicator1900, the silicone hinges 1902 can return to the relaxed state bypulling the petals down so that they can rotate in the direction ofarrow 1910 around their hinged lower edges 1826 until they rest upon thesupportive shelf 1811. The silicone hinges 1902 can bias the petals 1820into the deployed state so that the pessary 1800 remains in the deployedstate within the vaginal canal. In various embodiments, the pessary 1800can be free of silicone hinges 1902, the petals 1820 can be allowed toover-rotate further in the direction of arrow 1910, so that the petalspoint slightly downwards, and can therefore be maintained in thedeployed position by the natural downward force exerted on the pessary1800 by the descending organs.

FIGS. 20-26 depict various alternative embodiments for the designs ofthe petal members as unitary petal members. These unitary petal memberscan be incorporated into various embodiments described herein, and caninclude features of the various embodiments. FIG. 20 is a view of aunitary petal member for a pessary, according to an embodiment. Aunitary petal member 2000 for a pessary is shown in a fully extended anddeployed state. The unitary petal member 2000 can be circular in shapeand can includes a flexible and soft overmolding 2002 with multiplesupport members 2004 arranged within the unitary petal member 2000.Connection points 2008 can be hinged or otherwise connected to a stem(not shown). Cutout grooves 2010 can facilitate the collapse of theunitary petal member 2000 into a collapsed state with a smaller diameterfor ease of insertion and removal.

FIG. 21 is a top view of a unitary petal member for a pessary, accordingto an embodiment. The unitary petal member 2100 is shown in a fullyextended and deployed state. The unitary petal member 2100 can becircular in shape and can include a flexible and soft overmolding 2102with multiple support members 2104 arranged within the unitary petalmember 2100. The unitary petal member 2100 is shown with four supportmembers 2104, however, a unitary petal member can have more or fewersupport members 2104. Connection points 2108 can be hinged or otherwiseconnected to a stem (not shown). Cutout grooves 2110 can be widelydispersed and can be located along the interior surface of the unitarypetal member to facilitate the collapse of the unitary petal member intoa collapsed state with a smaller diameter for ease of insertion andremoval. The cutout grooves can be spaced widely between the supportmembers 2104.

FIG. 22 is a top view of a unitary petal member for a pessary with threesupport members, according to an embodiment. A unitary petal member 2200is shown in a fully extended and deployed state. The unitary petalmember 2200 can be circular in shape and can include a flexible and softovermolding 2202 with three support members 2204 arranged within theunitary petal member 2200. Connection points 2208 can be hinged orotherwise connected to a stem (not shown). Cutout grooves 2210 arewidely dispersed and are located along the interior surface of theunitary petal member facilitate the collapse of the unitary petal memberinto a collapsed state with a smaller diameter for ease of insertion andremoval.

FIG. 23 is a view of a unitary petal member for a pessary with closelyarranged cutout grooves, according to an embodiment. The unitary petalmember 2300 can be circular in shape and can include a flexible and softovermolding 2302 with multiple support members 2304 arranged within theunitary petal member 2300. Connection points 2308 can be hinged orotherwise connected to a stem (not shown). Cutout grooves 2310 can benarrowly arranged with respect to each other and can located along theinterior surface of the unitary petal member to facilitate the collapseof the unitary petal member into a collapsed state with a smallerdiameter for ease of insertion and removal.

FIG. 24 is a view of a unitary petal member for a pessary with petallobes, according to an embodiment. The unitary petal member 2400 canhave a plurality of petal lobes 2402. In an embodiment, the unitarypetal member can be provided with four petal lobes 2402, however, it isexpressly contemplated that the unitary petal member can be providedwith more than four petal lobes, or less than four petal lobes invarious embodiments. The petal lobes 2402 can be joined at a central hub2404. The petal lobes 2402 can include internal supports 2406. Thecentral hub and/or petal lobes can be flexible to provide for transitionfrom collapsed state to deployed state and a narrower diameter while inthe collapsed state.

FIG. 25 is a view of a unitary petal member for a pessary with acircular profile, according to an embodiment. A unitary petal member2500 can have a circular outer rim 2501 that can be a ring shape. Acentral hub 2502 can be connected to the outer rim 2501 by spokes 2506.While the illustrative unitary petal member includes four spokes 2506,it is contemplated that it can be provided with more than four or lessthan four spokes. The central hub and/or petal lobes can be flexible toprovide for transition from collapsed state to deployed state and anarrower diameter while in the collapsed state.

FIG. 26 is a view of a unitary petal member for a pessary with a lobedouter rim, according to an embodiment. A unitary petal member 2600 canhave an outer rim 2601, and outer rim 2601 can have multiple lobes 2604.Outer rim 2601 is shown with four lobes 2604, however, an outer rim 2601can have more or fewer lobes than four. A central hub 2602 can beconnected to the outer rim 2601 by spokes 2606. While the illustrativeunitary petal member includes four spokes 2606, it is contemplated thatin other embodiments, the petal member can be provided with more thanfour or less than four spokes. The outer rim 2601 can include widelydispersed grooves 2620 to facilitate collapse. The central hub and/orpetal lobes can be flexible to provide for transition from collapsedstate to deployed state and a narrower diameter while in the collapsedstate.

FIGS. 27-30 depict various cavity designs for the connection of thepetal members to the top of the stem. FIG. 27 is a view of a stem withrectangular cavities for petal members, according to an embodiment. Thetop of a stem 2700 can be provided with multiple rectangular-shapedcavities 2702 that can function as seats for holding petal members. Thestem 2700 can have passages 2704 that connect to the cavities 2702.Petal members (not shown) can have a cord that extends from the base ofthe petal through the passage 2704. When the cord is pulled, the base ofthe petal member can be pulled into the cavity so that when the petalmember is engaged within the cavity, the petal member can be held in adeployed position with the petal member extending outwards from thecavity. In various embodiments, the cord can be a string, a wire, etc.

FIG. 28 is a view of a stem with trapezoidal cavities for petal members,according to an embodiment. The top of a stem 2800 can be provided withmultiple trapezoidal-shaped cavities 2802 that can function as seats forholding petal members. The stem 2800 can have passages 2804 that connectto the cavities 2802. Petal members (not shown) can have a cord thatextends from the base of the petal through the passage 2804. When thecord is pulled, the base of the petal member can be pulled into thecavity so that while the petal member is engaged within the cavity, thepetal member can be held in a deployed position with the petal memberextending outwards from the cavity. Turning back to FIG. 27, therectangular cavities can hold the petal members in a more fixed positioncompared to the trapezoidal cavities of FIG. 28. The trapezoidalcavities 2802 can allow increased movement of the petal members up anddown compared to the rectangular cavities of FIG. 27.

FIG. 29 is a view of a stem with an alternate cavity shape, according toan embodiment. The top of a stem 2900 can have multiple cavities 2902that can function as seats for holding petal members. Cavities 2902 canhave a floor that can support the petal members (not shown) in asubstantially horizontal position in the deployed state. The cavities2902 can have a sloped ceiling that can allow the petal members to beangled upwards during removal of the pessary. The stem 2900 can havepassages 2904 that can connect to the cavities 2902. Petal members (notshown) can have a cord that extends from the base of the petal throughthe passage 2904.

FIG. 30 is a view of a stem with a cavities having no ceiling, accordingto an embodiment. The top of stem 3000 can have multiple cavities 3002.Cavities 3002 can have a floor that can support the petal members (notshown) in a substantially horizontal position in the deployed state. Thecavities 3002 can be free of ceilings, so that the petal members canrotate upwards into a substantially vertical position in the collapsedstate. The stem 3000 can have passages 3004 that can connect to thecavities 3002. Petal members can have a cord that extends from the baseof the petal through the passage 3004. When the cord is pulled, thepetal member can be pulled into the cavity 3002 so that the petal membercan be held in a deployed position extending outward from the stem 3000.When the cord is relaxed, the petal members can rotate upwards into acollapsed state to facilitate insertion or removal of the pessary.

FIG. 31 is a partial cutaway view showing the inner workings of apessary with a rigid stem cap for holding petals in place in a deployedstate, according to an embodiment. A pessary 3100 with a rigid stem capcan have a stem 3102 with a rigid stem cap 3104, a plunger cap 3106, andpetal members 3110. Petal members 3110 can have an elongated segment3112, a short segment 3114, a bend 3116 between the elongated segment3112 and the short segment 3114, and a hinge 3118 at the bend 3116. Thebend 3116 can have an obtuse angle, so that the short segments 3114 andthe elongated segments 3112 can be fixed at an angle greater than 90degrees relative to each other. The petal members 3110 can be attachedto the stem 3102 at the hinge 3118. FIG. 31 depicts the pessary with arigid stem cap 3104 in a collapsed state. In the collapsed state, theplunger cap 3106 can be in a down position, as shown in FIG. 31, therebyallowing the short segments 3114 to be in a downward position within thestem 3102. In this collapsed state with the short segments in a downwardposition within the stem, the elongated segments 3112 can rest againstthe rigid stem cap 3104, and the pessary can have a smaller diameterthan in the deployed state. In various embodiments, an inner wall of thestem 3102 can have an interengaging feature such as bumps or a ridge3120, and a stem cap 3104 can have a corresponding interengaging featuresuch as a divot or groove 3122, so that the interengaging features canhold the stem cap up in the deployed state.

FIG. 32 is a partial cutaway view showing the inner workings of thepessary with a rigid stem cap of FIG. 31, shown in a deployed state,according to an embodiment. When the plunger cap 3106 is pushed up intothe stem 3102, the plunger cap 3106 can push the short segments 3114upwards, which can cause the petal members 3110 to rotate on the hinge3118 until the elongated segments 3112 are in a deployed position. Theridge 3120 can be engaged with the groove 3122 to hold the pessary inthe deployed position. In the embodiment shown in FIG. 32, the stem 3102does not have (is free of) a shelf. In this embodiment without a shelf,the rigid stem cap 3104 can hold the petal members 3110 in the deployedposition with the elongated segments 3112 extending outwards. When thepetal members 3110 are rotated into the deployed position, the rigidstem cap 3104 can prevent the petal members 3110 from rotating beyondthe deployed position. The short segments 3114 can be held in placebetween the plunger cap 3106 and the rigid stem cap 3104, so that theelongated segments 3112 can be maintained in the deployed position. Whenthe plunger is pulled down, the short segments 3114 can rotate down intothe stem 3102 and the elongated segments can rotate upwards back intothe collapsed state shown in FIG. 31.

FIG. 33 is a partial cutaway view showing the inner workings of apessary with petals that can be held in place by a plunger, shown in acollapsed state. A pessary 3300 can have a stem 3302, a plunger 3304with a plunger cap 3306, and petal members 3310. Petal members 3310 canhave an elongated segment 3312, an intermediate segment 3314, and ashort segment 3316. The petals 3310 can be maintained in the collapsedstate by the plunger 3304. In the collapsed state with the plunger inthe down position, the short segment 3316 can rest against the side ofthe plunger cap 3306, so that the plunger cap 3306 can prevent the shortsegment 3316 from rotating inwards. By preventing the short segments3316 from rotating inwards, the plunger cap 3306 also prevents theelongated segments 3312 from rotating outwards into the deployedposition. When the plunger 3304 is pushed up into the stem 3302, theplunger cap 3306 can push upwards on the intermediate segments 3314,causing the intermediate segments 3314 to rotate up and out, and therebycausing the elongated segments 3312 to rotate out and down into thedeployed position.

FIG. 34 is a partial cutaway view showing the inner workings of thepessary of FIG. 33 with the petals in a deployed state, according to anembodiment. The pessary 3300 can be free of a supporting shelf for thepetal members 3310, and the petal members 3310 can be held in a deployedposition by the plunger cap 3306. In the deployed position, the shortsegments 3316 can contact the bottom of the plunger cap 3306. The bottomof the plunger cap 3306 can prevent the short segments 3316 fromrotating upwards. Because the plunger cap 3306 prevents the shortsegments 3316 from rotating upwards, the petal members 3310 cannotover-rotate out of the deployed position. There is no need for a shelfon the stem, because the plunger cap 3306 can maintain the petal members3310 in the deployed position, with the elongated segments 3312extending outwards. The plunger cap 3306 can also prevent theintermediate segments 3314 from rotating inwards. In the deployedposition, the intermediate segments 3314 can rest against the side ofthe plunger cap 3306, so that the petal members 3310 cannot rotate intothe collapsed position. The plunger cap 3306 can prevent the petalmembers 3310 from rotating into the collapsed position by preventing theintermediate segments 3314 from rotating inward and downward, and theplunger cap 3306 can prevent the petal members from over-rotating out ofthe deployed position with the elongated segments extending outward bypreventing the short segments 3316 from rotating upwards. The pessary3300 can be locked into the deployed position with the petal members3310 supported by the plunger cap 3306.

Pulling down on the plunger 3304 can cause the pessary 3300 totransition into the collapsed state. When the plunger 3304 is pulleddown, the bottom of the plunger cap 3306 can push down on the shortsegments 3316, thereby causing the short segments 3316 to rotatedownward and outward. When the short segments 3316 rotate downward, theelongated segments rotate upwards into the collapsed position.

FIG. 35 is a perspective view of a pessary with webbing between petals,according to an embodiment. A pessary 3500 can have a stem 3502, aplunger 3504, petal members 3510 with short segments 3512 and elongatedsegments 3514, and a petal webbing 3520. The petal webbing 3520 canconnect the petal members 3510, thereby forming a unitary petal member3530. The petal members 3510 and the petal webbing 3520 together canform a supportive surface that can work together to support the pelvicorgans. The petal webbing 3520 can be made of a silicone or otherdeformable material, so that the petal webbing 3520 can fold when thepessary 3500 is transitioned into the collapsed state. The petal webbing3520 can at least partially envelop the elongated segments 3514 with thesilicone or other material, as well as providing additional supportivematerial between the elongated segments 3514. The petal webbing 3520 isdepicted in FIG. 35 as a solid disc, however, the petal webbing can be aseries of concentric rings connecting the petal members 3510, or thepetal webbing 3520 can be a net or a mesh, or other arrangements ofmaterial connecting the petal members 3510. In various embodiments,unitary petal members such as the unitary petal members shown in FIGS.20-26 can be used in place of the unitary petal member 3520 shown inFIG. 35.

FIG. 36 is a perspective view of a domed pessary with resilientdeformable petals, according to an illustrative embodiment. A pessary3600 can have three or more resilient deformable petal members 3602 thatcan be joined at the top. Resilient deformable petal members 3602 can beribs defining a curved dome shape. Resilient deformable petal members3602 can be connected by a skin (not shown) forming a dome, and the skincan be a silicone overmolding, or other soft flexible material such assilicone. Resilient deformable petal members 3602 can have indentedfinger tabs 3604. A resilient deformable petal member 3602 can have anouter perimeter 3606, a recess portion 3608, and a finger tab 3604, sothat a radius distance from a central vertical axis to the outerperimeter 3606 is greater than a radius distance from the centralvertical axis to the finger tab 3604. The pessary 3600 can be insertedby pinching the finger tabs 3604 towards each other to decrease theoverall diameter of the pessary 3600, including the diameter at theouter perimeter 3606. Once the pessary 3600 is inserted, the finger tabs3604 can be released and the pessary can return to the resting stateshown in FIG. 36. To remove the pessary 3600, the finger tabs 3604 canbe pinched towards each other to decrease the overall diameter of thepessary 3600.

In various embodiments, a lower portion of the deformable petal members3602 can be connected by a string 3610 that can be a silicone, a nylonmaterial with a silicone coating, or other material. String 3610 can beconnected to each petal member 3602, and the strings from each petalmember can be joined together. The pessary can be removed by pulling onthe string 3610. Pulling on the string 3610 can cause the resilientdeformable petal members 3602 to move towards each other and decreasethe overall diameter of the pessary 3600, including the diameter at theouter perimeter 3606. Pulling on the string 3610 can also exert a forceon the pessary 3600 to remove the pessary as the deformable petalmembers 3602 have moved towards each other.

FIG. 37 is a perspective view of a pessary with resilient deformablemembers connected to a base ring, according to an embodiment. A pessary3700 can have 3 or more resilient deformable petal members 3702 that canbe joined at the top, and can be connected to a base ring 3704.Resilient deformable petal members 3702 can be ribs forming a curveddome shape. A soft skin 3706 can connect the resilient deformable petalmembers 3702 and/or the base ring 3704. Soft skin 3706 can be a softplastic, a silicone, or other biocompatible material. Base ring 3704 canhave one or more ring breaks 3708 in the internal structure of the basering 3704 to allow the base ring 3704 to be collapsed for easierinsertion and removal of the pessary 3700. Base ring 3704 can beovermolded with silicone or other soft biocompatible material, and thesilicone can cover or encapsulate the ring breaks 3708. Ring breaks 3708may not be complete cuts or gaps, but can be portions of the ring thatare thinner or otherwise weakened to allow easy collapsibility. Invarious embodiments, the pessary 3700 can have recess portions andfinger tabs to ease removal. In various embodiments, the pessary 3700can have strings connecting multiple lower portions of the base ring3704 or finger tabs, and the strings can be connected together. Pullingon the string can help to collapse the base ring 3704 and can help toremove the pessary 3700.

FIG. 38A is a side view of the domed pessary of FIG. 37 shown in acollapsed conformation, according to an illustrative embodiment. A usercan flatten or otherwise collapse the pessary 3700 by squeezing sides ofthe base ring 3704 together and collapsing the base ring 3704 at thering breaks 3708. Ring breaks 3708 are shown exposed and withoutsilicone overmolding in FIG. 38A for clarity, but it should be clearthat ring breaks 3708 can be encapsulated to avoid protruding edges.FIG. 38B is a bottom view of the domed pessary of FIG. 37 shown in acollapsed conformation, according to an illustrative embodiment. Thebase ring 3704 can have two or more ring breaks 3708 to allow easycollapsibility for ease of insertion. Pessary 3700 can have petal breaks3802 where the resilient deformable petal members 3702 meet the ring3704. Petal breaks 3802 can allow the pessary 3700 to collapse morefully for ease of insertion. The pessary 3700 can be overmolded withsilicone or other soft biocompatible material, and the silicone cancover or encapsulate the petal breaks 3802. Petal breaks 3802 may not becomplete cuts or gaps, but can be portions of the resilient deformablepetal members 3702 that are thinner or otherwise weakened to allow easycollapsibility. When the pessary 3700 is released, the resilientdeformable petal members 3702 can bias the pessary into the deployedconformation shown in FIG. 37. FIG. 38C is a top view of the domedpessary of FIG. 37 shown in a deployed conformation. When a userreleases the pessary, the resilient deformable petal members 3702 canreturn to their unstressed conformation and can bias the pessary 3700into the deployed conformation.

FIG. 39A is a diagram of a figure-eight pessary in a deployedconformation, according to an illustrative embodiment. A figureeight-shaped pessary 3900 in a deployed conformation can have astructural frame with three or more helical petal members 3902. Theexemplary figure-eight pessary in FIG. 39A is shown with four helicalpetal members 3902. The helical petal members 3902 can be joined at theapex 3904 and at the bottom 3906. The figure-eight pessary 3900 can havea central union 3908, and the helical petal members 3902 can be hingedlyjoined at the central union 3908. The portion of the figure-eightpessary 3900 between the apex 3904 and the central union 3908 can be asupportive portion 3910, and the portion of the pessary between thecentral union 3908 and the bottom 3906 can be a pinchable handle portion3912.

A helical petal member 3902 can have an upper hinge 3920 at the largestdiameter section of the supportive portion, and a lower hinge 3922 atthe largest diameter section of the pinchable handle portion. The regionof the petal member 3902 between the upper hinges 3920 and the apex 3904can be a top region 3930, the region of the petal member 3902 betweenthe upper hinges 3920 and the lower hinges 3922 can be a middle region3932, and the region of the petal member 3902 between the lower hinges3922 and the bottom 3906 can be a lower region 3934. The upper region3930 can provide support for the pelvic organs.

The apex 3904 and the bottom 3906 can be connected with a tensioner3940. Tensioner 3940 can include an elastic cord or a tension springbetween the apex 3904 and the bottom 3906. The tension force between theapex 3904 and the bottom 3906 can bias the pessary into the deployedconformation shown in FIG. 39A. The figure-eight pessary 3900 can have asilicone overmolding, and the silicone overmolding can be molded overthe frame in the deployed conformation, so that the silicone overmoldingcan bias the figure-eight pessary 3900 in the deployed conformation. Theframe of the pessary 3900 can be molded or otherwise constructed in thedeployed conformation, so that the frame biases the pessary 3900 intothe deployed conformation. The figure-eight pessary 3900 can becollapsed by pinching the lower portion of the figure-eight pessary, andthe figure-eight pessary can return to a resting deployed conformationwhen the lower portion is released.

FIG. 39B is a detailed view of the apex region A from FIG. 39A,according to an illustrative embodiment. In various embodiments, theapex 3904 and/or bottom 3906 can be molded or otherwise constructed witha resilient deformable unitary joint between the petal members 3902. Theframe can be molded with a unitary apex 3904 with the petal members 3902extending outward in the deployed conformation. The resilient deformableunitary joint can be semi-rigid, and can bias the frame into thedeployed conformation.

FIG. 39C is a detailed view of the hinge region B from FIG. 39A,according to an illustrative embodiment. In various embodiments, upperhinge 3920 and/or lower hinge 3922 can be a unitary hinge. A portion ofthe petal member 3902 can be removed to create a thinner section 3950,or the petal member can be molded with a thinner section 3950 and a gap3952. The living hinge can allow the frame to bend easily into thedeployed conformation.

FIG. 39D is a detailed view of the hinge region B from FIG. 39A,according to another illustrative embodiment. In various embodiments,the upper region 3930, middle region 3932, and lower region 3934 of thepetal members 3902 can be distinct components. A pivoting hinge canconnect the upper region 3930 and the middle region 3932, so that theregions of the petal members can rotate freely relative to each other,and/or a pivoting hinge can connect the middle region 3932 and the lowerregion 3934 of the petal members so that the regions of the petalmembers can rotate freely relative to each other. The pivoting hinge caninclude a pin 3960 connecting regions of the petal member so that theregions of the petal member can rotate around the pin 3960.

FIG. 39E is a detailed view of the central union region C from FIG. 39A,according to an illustrative embodiment. In various embodiments, acentral union 3908 can include a union ring 3970. Union ring 3970 canhave a rectangular cross section, and the petal members 3902 can havemating slots 3972 that can be sized and shaped to accommodate the unionring 3970. The mating slots 3972 can define at least a portion of ashape that is larger than the cross section of the union ring 3970, sothat the union ring 3970 can be snapped into the slots 3972, and theslots 3972 can retain the union ring 3970. The union ring can havemechanical stops 3974 that can be bumps or other extensions outward fromthe union ring between the petal members 3902. The mechanical stops 3974can prevent the petal members 3902 from sliding around the union ring3970.

The supportive portion 3910 of the petal members 3902 can rotate, orlean over, along arrow 3976 to reach the fully deployed conformation,while the pinchable handle portion 3912 of the petal members 3902 canrotate, or lean, along arrow 3978 to reach the fully deployedconformation. In a fully deployed conformation, petal members 3902 canbe at a minimum angle MA relative to the union ring 3970, and the upperdiameter of the supportive portion of the frame at the upper hinges 3920can be at the maximum diameter. The mating slots 3972 can have a maximumheight MH that can limit how far the petal members can rotate relativeto the union ring 3970, thereby limiting the maximum diameter of thesupportive portion at the upper hinges. Limiting the maximum diameter ofthe supportive portion can increase comfort for the user of the pessary.When the user pinches the pinchable handle region of the frame in aregion that can include the lower hinges 3922, the petal members canrotate relative to the union ring 3970 in a direction opposite to arrows3976 and 3978, and the angle of the petal members 3902 relative to theunion ring 3970 can increase.

FIG. 40A is a diagram of a figure-eight pessary in a collapsedconformation, according to an illustrative embodiment. In the collapsedstate, the petal members 3902 have been deformed out of the helicalshape of the deployed conformation, and are now in a more verticalarrangement. A user can apply a pinching force along arrows 4002 at ornear the lower hinges 3922 to squeeze the lower hinges 3922 towards eachother, thereby elongating the pessary 3900, and decreasing the diameterof the pessary 3900 at the upper hinges 3920.

The petal members 3902 can be molded into the helical shape shown inFIG. 39A, so that a force is required to deform the petal members 3902out of the helical shape and into the shape shown in FIG. 40A, and themolded shape of the petal members 3902 can bias the pessary 3900 backinto the deployed conformation of FIG. 39A when the pessary 3900 isreleased by the user. A silicone overmolding can be molded over thepessary 3900 in the deployed conformation, and the silicone overmoldingcan bias the pessary into the deployed conformation. A unitary joint atthe apex and/or the bottom of the pessary can bias the pessary into thedeployed conformation. A tensioner can bias the pessary into thedeployed conformation.

FIG. 40B is a detailed view of the central union region A from FIG. 40A,according to an illustrative embodiment. Petal members 3902 are now in amore vertical arrangement, and petal members 3902 are at a maximum angleXA relative to the union ring. Mating slots 3972 are taller than theunion ring 3970, and now have extra space at the top and/or bottom themating slot 3972. The width of the mating slots 3972 can beapproximately the same as the width of the cross section of the unionring 3970, so that the petal members can pivot side to side, but cannotrock in and out. Mechanical stops 3974 prevent the petal members 3902from sliding around the union ring 3970.

FIG. 41 is a diagram of a pessary with petals that rotate about acentral axis, according to an illustrative embodiment. A pessary 4100can have at least two rigid petals 4102, 4104 that can rotate about acentral axis 4106. In the deployed state, the upper petal 4102 can berotated into a position that is rotationally remote from the lower petal4104. In various embodiments, pessary 4100 can have a knob 4108 that canbe rotated to rotate the lower petal 4104 from the collapsed state tothe deployed state relative to the upper petal 4102, and/or from thedeployed state to the collapsed state. Various means can be used forbiasing the pessary into a deployed state.

FIG. 42A is a partially cutaway diagram of the pessary of FIG. 41showing inner workings of the pivoting hinge and shown in a collapsedstate, according to an illustrative embodiment. In a collapsed state,the lower petal 4104 can be parallel to the upper petal 4102. The upperpetal 4102 can have an upper hinging member 4210, and the lower petal4104 can have a lower hinging member 4220. The lower hinging member 4220can have a tooth 4222 extending radially outward from the lower hingingmember 4220. The upper hinging member 4210 can have a locking recess4212 and a slide 4214. The upper petal 4102 can be biased towards thelower petal 4104 by various means that can include a tensioner such as atension spring inside of the hinge, or a silicone overmoldingsurrounding the pivoting hinge that has been molded around the pivotinghinge in the deployed position. As the upper petal 4102 and the lowerpetal member 4104 are biased towards each other, the lower petal 4104rotates along arrow 4230 relative to the upper petal 4202, and the tooth4222 is urged along the slide 4214 and into the locking recess 4212.When the tooth 4222 is in the locking recess 4212 the pessary is in arelaxed and deployed state.

FIG. 42B is a cutaway view of a central pivoting hinge for the pessaryof FIG. 41 showing inner workings and shown in a deployed state,according to an illustrative embodiment. In the deployed state, thetooth 4222 is held within the locking recess 4212. The upper hingingmember 4210 and the lower hinging member 4220 are biased towards eachother, thereby holding the tooth 4222 within the locking recess 4212.

FIG. 43 is a cutaway view of a central pivoting hinge for the pessary ofFIG. 41 showing inner workings and in a deployed state, according toanother illustrative embodiment. Pessary 4100 can have a compressionspring 4302 that can bias the lower petal 4104 away from the upper petal4102, and the pessary 4100 can have a retention lip 4304 that can retainthe lower petal 4104 together with the upper petal 4102, therebylimiting how far the compression spring 4302 can force the lower petal4104 away from the upper petal 4102. The lower petal 4104 can have agroove 4306 that can travel along a thread 4308 on the upper petal 4102.In the relaxed and deployed state shown in FIG. 43, the compressionspring has forced the lower petal 4104 to rotate and travel downwardsalong thread 4308, and the lower petal 4102 is at the most distant pointfrom the upper petal 4104. To insert the pessary, a user can rotate thelower petal 4104 upwards and around the thread 4308 into the collapsedstate, and when the user releases the pessary the compression spring4302 can return the pessary to the deployed state.

FIG. 44 is a perspective view of a pessary with enclosed rotatingpetals, according to an illustrative embodiment. A pessary 4400 can havean outer petal 4402 and an inner petal 4404 that can rotate relative toeach other around a central axis. The outer petal 4402 can be a rigidmember with an inner chamber 4406 that can accommodate the inner petal4402. Outer petal 4402 can be overmolded with a silicone casing 4408that can encapsulate the outer petal 4402 and the inner petal 4404. Invarious embodiments, the silicone overmolding can have holes that canallow for drainage. The inner petal 4404 can be rotationally remote fromthe inner petal 4404 in the deployed state shown in FIG. 44. FIG. 45 isa perspective view of the pessary of FIG. 44, shown in the collapsedstate. Inner petal 4404 can rotate into the inner chamber 4406 of theouter petal 4402. Rotating the inner petal 4404 into the inner chamber4406 can decrease the size of the pessary so that it can be insertedinto the vaginal canal. FIG. 46 is a cross section of the pessary ofFIG. 44 in the deployed state, taken along line 46-46 of FIG. 44,according to an illustrative embodiment. The pessary 4400 can have oneor more torsion springs 4602 that can bias the inner petal 4404 into adeployed state that is rotationally remote from the outer petal 4402.The torsion spring 4602 can be connected to, or can press against,spring tabs 4604 on the outer petal 4402 and the inner petal 4404.

The pessary 4400 can be manufactured by molding the outer petal in twohalves along line 46-46 of FIG. 44, and then overmolding the siliconecasing around each half separately. The pessary 4400 can then beassembled by snapping the two halves of the outer petal together aroundthe inner petal. An additional layer of silicone overmolding can thenseal the snap at the seam.

FIG. 47 is a partially cutaway view of a rotating pessary that can bedisassembled for cleaning, according to an illustrative embodiment. Arotating pessary 4700 can have an upper petal 4702 and a lower petal4704. Upper petal 4702 and lower petal 4704 can have a siliconeovermolding 4706 that can increase comfort for the user. Upper petal4702 can include an axle 4708, and the lower petal 4704 can rotatearound the axle 4706. The pessary 4700 can have a removable endcap 4710.A user can remove the endcap 4710 from the axle 4708 to disassemble thepessary 4700. The lower petal 4704 can be separated from the upper petal4702 so that each component can be cleaned separately.

FIG. 48 is a perspective view of a pessary with a sliding ring lock,according to an illustrative embodiment. A pessary 4800 can have threeor more hinged petals 4802 that can be joined together at an apex 4804.Petal members 4802 can have an upper hinge 4806, a middle hinge 4808,and a lower hinge 4810. The petal members 4802 can be attached to asliding ring 4812 that can slide along a central stem 4814. Sliding ring4812 can slide along the central stem 4814 to move the pessary 4800between a deployed state and a collapsed state. In various embodiments asilicone overmolding, or other soft material can surround the petalmembers 4802.

FIG. 49 is a perspective view of the pessary of FIG. 48 in a collapsedstate, according to an illustrative embodiment. The sliding ring 4812can be at the lowest position along the central stem 4814, and upperhinges 4806 and lower hinges 4810 can be bent. FIG. 50 is a perspectiveview of the pessary of FIG. 48 in a deployed state, according to anillustrative embodiment. The sliding ring can be at the highest positionalong the central stem 4814, and the middle hinges 4808 can be bent. Inthe deployed position, the petals 4802 are extending radially outwardfrom the central stem, and the diameter of the pessary around the middlehinges 4808 is at a maximum diameter. In various embodiments, a siliconeovermolding 5002 or other soft material that can surround the petals canbe expanded outwards with the petals, so that the petals 3802 and thesilicone overmolding together can support the pelvic organs.

FIG. 51A is a perspective view of a locking mechanism for the pessary ofFIG. 48, according to an illustrative embodiment. The central stem 4814can have one or more locking bumps 5102 that extend outwards from thestem 4814. Stem 4814 can be hollow and/or flexible, and stem 4814 canflex to allow the sliding ring 4812 to pass over the locking bumps 5102.The locking bumps 5102 can retain the sliding ring 4812 in the upwardposition, thereby locking the petals 4802 in the deployed stateextending radially outward from the central stem 4814. A user canrelease the pessary 4800 from the deployed state by squeezing the stem4814 inward along arrows 5104, so that the sliding ring 4812 can passover the locking bumps 5102 and can slide downward on the stem 4814 intothe collapsed state.

FIG. 51B is a partially cut away perspective view of a locking mechanismfor the pessary of FIG. 48 and shown in a deployed state, according toanother illustrative embodiment. The central stem of the pessary caninclude an outer sleeve 5110 and an inner slider 5112 that can slide, ortelescope, within the outer sleeve 5110. The tops of the petals 4802 canbe attached at a top of the slider, and the bottoms of the petals 4802can be attached to the sleeve. Although only two petals are shown inFIG. 51B for clarity, it should be clear that the pessary can have morethan two petals 4802. The inner slider 5112 can have a ridge 5114 or liparound at least a portion of the circumference of the inner slider 5112,and the outer sleeve 5110 can have one or more bumps 5116 or extensionsthat can extend inward from an interior wall of the slider. The bumps5116 and the ridge 5114 can limit the movement of the pessary between adeployed state and a collapsed state, because a force must be exerted onthe pessary to move the ridge 5114 past the bumps 5116. Additionally,the pessary can be molded so that it is biased to the deployed stage, orit can have a spring (not shown) biasing it to the deployed stage whichstretches in the collapsed state.

51C is a partially cut away perspective view of a locking mechanismpessary of FIG. 51B and shown in a collapsed state, according to theillustrative embodiment. To collapse the pessary, a user can pull on theouter sleeve so that the bumps 5116 can move past the ridge 5114 and theouter sleeve 5110 can move relative to the inner slider 5112. When auser pulls on the outer sleeve to remove the stem from the vagina, theouter sleeve can extend away from the petals, and the pessary cancollapse. As the pessary collapses, the petals can fold upwards for easeof removal. In various embodiments, the outer sleeve can be providedwith a string 5118, so that a user can pull on the string in removingthe pessary.

FIG. 51D is a partial perspective view of an upper portion of a pessarywith a sliding ring, according to another embodiment. Turning to FIGS.48 and 51D, the upper portion of a pessary as shown in FIG. 51D can beadapted for use with a sliding ring and stem as shown in FIG. 48. Apessary 51D can have a sliding ring that can be free of a lockingmechanism. A pessary 5110 can have a plurality of rigid or semi rigidpetals 5112 that can be rotatably connected to a fixed upper ring 5114,pins, or other rotatable hinging mechanisms. Petals 5112 can have anupper hinge 5116 where petal members rotate around a ring 5114, a middlehinge 4808 that can include a pin or other rotating hinge, and a lowerhinge 4810 at or near sliding ring 4812. In various embodiments asilicone overmolding, or other soft material can surround the petals5112. Sliding ring 4812 can slide along the central stem 4814 to movethe pessary 5110 between a deployed state and a collapsed state.

FIG. 51E is a partial perspective view of the upper portion of thepessary of FIG. 51D shown in a collapsed state, according to theembodiment. A user can slide the sliding ring 4812 downwards totransform the pessary 5110 into the collapsed state with a minimumdiameter for insertion. After the pessary has been inserted, the usercan slide the sliding ring upwards to transform the pessary into thedeployed state. After the pessary 5110 has been inserted and is in thedeployed conformation, the pessary can remain in the deployed,supportive state shown in FIG. 38A due to the placement of the pessary5110 in the body and the natural distribution of forces within the body.The majority of forces acting on the pessary 5110 while the pessary isin the deployed conformation within the body are exerted downwards onthe pessary, thereby maintaining the pessary in a stable and supportivedeployed conformation. The tops of the petals 5112 can be cut orotherwise manufactured with interlocking angled ends 5118 so that in thedeployed state they can meet at the apex to form a smooth dome top.

FIG. 52 is a top view of a pessary with a rotating ring lock, accordingto an illustrative embodiment. A pessary 5200 can have a plurality ofbroad petals 5202 that can support the pelvic organs. Petals 5202 can beattached to a stem 5204 at flexible joints 5206. A rotating ring lock5208 can have extended locking portions 5210 and notches 5212. Theextended locking portions 5210 can extend radially outward beyond theflexible joints 5206 to support the petals 5202. In various embodimentsthe pessary can have a silicone overmolding that forms a webbing betweenthe petals. The rotating ring lock 5208 can be rotated in the directionof arrow 5214 to unlock the pessary 5200. When the notches 5212 areunder the flexible joints 5206 the petals 5202 can fold downwards intothe collapsed position. FIG. 53 is a cross sectional view of the pessarywith a rotating ring lock taken along cross section line 53-53 of FIG.52, according to an illustrative embodiment. An extended locking portion5210 is shown extending under the petal 5202 and supporting the petal5202 in the deployed state.

FIG. 54 is a top view of a pessary with a rotating ring lock in acollapsed state, according to an illustrative embodiment. The rotatingring 5208 lock has been rotated around the stem 5204 so that the notches5212 are under the flexible joints 5206. Petals 5202 are bent downwardsthrough the notches 5212 into the collapsed state. FIG. 55 is a crosssectional view of the pessary of with a rotating ring lock in acollapsed state, taken along cross section line 55-55 of FIG. 54,according to an illustrative embodiment. Petals 5202 can be flexeddownward into the collapsed state, and the extend locking portions canextend outward between the petals 5202 without interfering with thepetals 5202 folding downward into the collapsed state.

FIG. 56 is a perspective view of a pessary with a twisting deploymentshown in a deployed state, according to an illustrative embodiment. Apessary 5600 can have a plurality of three or more petals 5602. Theupper ends of the petals 5602 can be flexibly joined to the top of thestem 5604, and petals can have a hinge 5606. The lower ends of thepetals 5602 can be flexibly joined to a sliding and rotating ring 5608that can slide along and rotate around the stem 5604. The pessary 5600can have a silicone overmolding 5610 connecting the petals 5602 to forma supportive webbing between the petals 5602.

FIG. 57 is a perspective view of the pessary with a twisting deploymentshown in a collapsed state, according to an illustrative embodiment.Ring 5608 can be slid downward along arrow 5702 and can be rotated alongarrow 5704 to transition the pessary 5600 into the collapsed state. Inthe collapsed state, petals 5602 can be elongated and twisted around thestem 5604 to minimize the diameter of the pessary 5600.

FIG. 58 is a perspective view of the pessary with a twisting deploymentof FIG. 56 showing a locking mechanism, according to an illustrativeembodiment. In FIG. 58, only two petals 5602 are shown for clarity, butit should be clear that pessary 5600 can have more than two petals. Stem5604 can have spiral grooves 5802, and ring 5608 can have one or morethreads that can slide within the spiral grooves 5802, so that the ring5608 can be guided through the motion up and down the stem 5604 and therotational motion around the stem 5604 at the same time. The stem 5604can have one or more locking bumps 5802 that extend outwards from thestem 5604. Stem 5604 can be hollow and/or flexible, and stem 5604 canflex to allow the sliding ring 5608 to pass over the locking bumps 5802.The locking bumps 5802 can retain the sliding ring 5608 in the upwardposition, thereby locking the petals 5602 in the deployed stateextending radially outward from the stem 5604. A user can release thepessary 5600 from the deployed state by squeezing the stem 5604 inwardalong arrows 5806, so that the sliding ring 5608 can pass over thelocking bumps 5802 and can slide downward on the stem 5604 into thecollapsed state.

FIG. 59 is a partially cut away perspective view of the pessary with atwisting deployment of FIG. 56 showing the interior of the petals,according to an illustrative embodiment. In FIG. 59, only two petals5602 are shown for clarity, but it should be clear that pessary 5600 canhave more than two petals. Petals 5602 can have rigid floats 5902 withinthe petals 5602, and the petals can include a silicone overmolding 5904that contains the rigid floats 5902. Silicone overmolding 5904 can formthe flexible joints between the top of the petals 5602 and the stem5604, the flexible joints between the bottom of the petals 5602 and thering 5608, and the joints 5606 in the petals 5602.

FIG. 60 is a perspective view of the pessary with a twisting deploymentof FIG. 56 showing living hinges, according to an illustrativeembodiment. In various embodiments, the petals 5602 can be moldedtogether as one part along with the sliding and rotating ring 5608 and afixed ring 6002. The fixed ring 6002 can be fixedly attached to the topof the stem 5604, so that the tops of the petals 5602 are held in afixed position relative to the top of the stem, and the petals can haveflexible joints where the petals meet the fixed ring. Petals 5602 canhave living hinges as part of the unitary structure between the petals5602 and the fixed ring 6002, and the petals can have living hinges aspart of the unitary structure between the petals 5602 and the slidingand rotating ring 5608. Petals 5602 can also have unitary living hingesat hinge 5606.

It should be clear to one of ordinary skill that the foregoing describesvarious embodiments of pessaries that can flexible and can assume asmaller diameter during insertion and removal for greater convenienceand comfort. The functions of the pessary and the variable geometry ofthe diameter can provide for easier handling by the user. This in turncan allow the user to provide their own personal care for the pessarywithout visiting a health practitioner, greater spontaneity forintimacy, and the ability to remove the pessary when not needed. Invarious embodiments, an overmolding of silicone or other flexiblematerial can form a webbing between petals to create a supportivestructure that can be collapsed during removal.

The foregoing has been a detailed description of illustrativeembodiments of the invention. Various modifications and additions can bemade without departing from the spirit and scope of this invention.Features of each of the various embodiments described above may becombined with features of other described embodiments as appropriate inorder to provide a multiplicity of feature combinations in associatednew embodiments. Furthermore, while the foregoing describes a number ofseparate embodiments of the apparatus and method of the presentinvention, what has been described herein is merely illustrative of theapplication of the principles of the present invention. For example, inother embodiments for insertion purposes, the pessary can include anapplicator that wholly or partially encases the pessary in its collapsedstate. The upward and downward motion of the plunger, as well asinsertion and removal of the pessary, can be accomplished bymanipulation of an applicator. The removal of the pessary can beperformed with an assisting applicator. The applicator can be a stringin further embodiments. The petals can be formed in a variety ofgeometries that all have in common the reduction of diameter in thecollapsed state. Also, as used herein, various directional andorientational terms (and grammatical variations thereof) such as“vertical”, “horizontal”, “up”, “down”, “bottom”, “top”, “side”,“front”, “rear”, “left”, “right”, “forward”, “rearward”, and the like,are used only as relative conventions and not as absolute orientationswith respect to a fixed coordinate system, such as the acting directionof gravity. Additionally, where the term “substantially” or“approximately” is employed with respect to a given measurement, valueor characteristic, it refers to a quantity that is within a normaloperating range to achieve desired results, but that includes somevariability due to inherent inaccuracy and error within the allowedtolerances (e.g. 1-2%) of the system. Accordingly, this description ismeant to be taken only by way of example, and not to otherwise limit thescope of this invention.

What is claimed is:
 1. A pessary comprising: a stem including an insertion end and a bottom end, the stem including a shelf at the insertion end; and at least one petal member hingedly attached to the insertion end of the stem, the at least one petal member being rotatable between a collapsed state and a deployed state, wherein in the deployed state the at least one petal member extends outward from the stem, and in the collapsed state the at least one petal member is rotated upwards, towards a top end of the pessary, so that a collapsed diameter of the pessary in the collapsed state is smaller than a deployed diameter of the pessary in the deployed state, wherein when the pessary is in the deployed state, a surface of the at least one petal member, facing the bottom end, is supported by the shelf.
 2. The pessary of claim 1, further comprising a plunger that moves within the stem along a vertical axis of the stem, wherein the plunger can slide away from the insertion end of the stem to allow the at least one petal member to rotate upwards into the collapsed state, and the plunger can slide towards the insertion end of the stem to push the at least one petal member into the deployed state.
 3. The pessary of claim 2, wherein the at least one petal member comprises an elongated segment, a short segment, and a bend between the elongated segment and the short segment, the elongated segment and the short segment being at a fixed angle relative to each other.
 4. The pessary of claim 3, wherein when the plunger is pushed towards the insertion end of the stem, a top of the plunger pushes upwards on the short segment causing the at least one petal member to rotate into the deployed state with the elongated segment extending outwards from the stem.
 5. The pessary of claim 3, further comprising a connection between the top of the plunger and the short segment of the at least one petal member, wherein when the plunger is pulled away from the insertion end of the stem, the top of the plunger pulls the short segment inwards and downwards, thereby rotating the elongated segment upwards into the collapsed state.
 6. The pessary of claim 3, further comprising a deformable membrane that is connected to and located between a plurality of short segments.
 7. The pessary of claim 6, wherein the deformable membrane is connected to the top of the plunger.
 8. The pessary of claim 3, wherein the at least one short segment is connected to the top of the plunger.
 9. The pessary of claim 3, the at least one petal member further comprising a tab at the bend, and the plunger cap further comprising at least one groove, wherein when the pessary is in a deployed state, the tab is engaged with the groove.
 10. The pessary of claim 2, further comprising a stem cap, wherein in a deployed position, the short segment is held between the plunger and the stem cap, thereby preventing the petal member from rotating out of the deployed position.
 11. The pessary of claim 2, the petal member further comprising an intermediate segment, wherein in a deployed state, the plunger can prevent the short segment from rotating upwards, thereby preventing the petal member from over-rotating out of the deployed position, and the plunger can prevent the intermediate segment from rotating inwards, thereby preventing the petal member from rotating back to the collapsed state.
 12. The pessary of claim 1, further comprising at least one sliding hinge between the stem and the at least one petal member, the at least one sliding hinge hingedly attached to the at least one petal member, and the at least one sliding hinge slidably attached within the interior of the stem, the sliding hinge sliding along the interior of the stem in a direction parallel to the vertical axis.
 13. The pessary of claim 1, wherein the at least one petal member comprises at least two petal members, the pessary further comprising a petal webbing between the petal members, the petal members and the petal webbing forming a unitary petal member.
 14. The pessary of claim 1, wherein the at least one petal member comprises at least two petal members, the pessary further comprising an outer rim, wherein the outer rim connects the at least two petal members, thereby forming a unitary petal member.
 15. The pessary of claim 1, wherein in the collapsed state the at least one petal member is substantially parallel to a vertical axis of the stem. 